CA2184581A1 - Improved dnase liquid solutions - Google Patents

Improved dnase liquid solutions

Info

Publication number
CA2184581A1
CA2184581A1 CA002184581A CA2184581A CA2184581A1 CA 2184581 A1 CA2184581 A1 CA 2184581A1 CA 002184581 A CA002184581 A CA 002184581A CA 2184581 A CA2184581 A CA 2184581A CA 2184581 A1 CA2184581 A1 CA 2184581A1
Authority
CA
Canada
Prior art keywords
dnase
solutions
calcium ion
liquid solutions
thermal aggregation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002184581A
Other languages
French (fr)
Other versions
CA2184581C (en
Inventor
Hak-Kim Chan
Igor Gonda
Steven J. Shire
Susanne Sin-Mui Lo Weck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genentech Inc
Original Assignee
Hak-Kim Chan
Igor Gonda
Steven J. Shire
Susanne Sin-Mui Lo Weck
Genentech, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hak-Kim Chan, Igor Gonda, Steven J. Shire, Susanne Sin-Mui Lo Weck, Genentech, Inc. filed Critical Hak-Kim Chan
Publication of CA2184581A1 publication Critical patent/CA2184581A1/en
Application granted granted Critical
Publication of CA2184581C publication Critical patent/CA2184581C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • C12N9/22—Ribonucleases RNAses, DNAses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/018—Hydrolysed proteins; Derivatives thereof from animals from milk
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/10—Expectorants
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/21—Endodeoxyribonucleases producing 5'-phosphomonoesters (3.1.21)
    • C12Y301/21001—Deoxyribonuclease I (3.1.21.1)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Abstract

The present invention relates to the use of calcium ion and/or sugars to minimize thermal aggregation of DNase and to the use of calcium ion to stabilize liquid solutions of DNase, the solutions having a pH of less than neutral. DNase is the active pharmaceutical principle and the solutions may contain other pharmaceutically acceptable excipients making them suitable for pharmaceutical administration. In the first instance, calcium ion/sugar minimizes the effects of thermal aggregation in the solution. In the second aspect, calcium ion stabilizes the lower pH solutions from protein precipitation.
CA002184581A 1994-03-04 1995-02-28 Improved dnase liquid solutions Expired - Lifetime CA2184581C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US20650494A 1994-03-04 1994-03-04
US08/206504 1994-03-04
US37752795A 1995-01-20 1995-01-20
US08/377527 1995-01-20
PCT/US1995/002457 WO1995023854A1 (en) 1994-03-04 1995-02-28 IMPROVED DNase LIQUID SOLUTIONS

Publications (2)

Publication Number Publication Date
CA2184581A1 true CA2184581A1 (en) 1995-09-08
CA2184581C CA2184581C (en) 2005-02-22

Family

ID=26901408

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002184581A Expired - Lifetime CA2184581C (en) 1994-03-04 1995-02-28 Improved dnase liquid solutions

Country Status (7)

Country Link
US (2) US6383788B1 (en)
EP (1) EP0748377B1 (en)
JP (1) JP3009224B2 (en)
AT (1) ATE401394T1 (en)
CA (1) CA2184581C (en)
DE (1) DE69535787D1 (en)
WO (1) WO1995023854A1 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6383788B1 (en) * 1994-03-04 2002-05-07 Genentech, Inc. Minimizing thermally induced aggregation of DNase in solution with calcium
CA2264885A1 (en) * 1996-09-04 1998-03-12 Nexell Therapeutics Inc. Compositions containing nucleases and chelators to enhance the recovery of cells during cell separating procedures
IL155002A0 (en) 2000-10-12 2003-10-31 Genentech Inc Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
CA2754528A1 (en) 2009-03-06 2010-09-10 Genetech, Inc. Antibody formulation
US20140005128A1 (en) 2010-08-11 2014-01-02 Forest Laboratories Holdings Limited Treatments of gastrointestinal disorders
EP3214172B1 (en) 2014-10-31 2019-02-13 JCR Pharmaceuticals CO., LTD. Method for producing remcombinant human dnasei
US11225648B2 (en) * 2015-01-04 2022-01-18 Protalix Ltd. Modified DNase and uses thereof
WO2017049205A2 (en) * 2015-09-18 2017-03-23 Amunix Operating Inc. Growth hormone formulation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3042587A (en) * 1960-11-29 1962-07-03 Merck & Co Inc Stabilized desoxyribonuclease preparation
CA1059937A (en) 1975-03-25 1979-08-07 Boen T. Khouw Isolation and purification of deoxyribonuclease
US4233405A (en) * 1979-10-10 1980-11-11 Rohm And Haas Company Process for spray drying enzymes
WO1990007572A1 (en) * 1988-12-23 1990-07-12 Genentech, Inc. HUMAN DNase
US5279823A (en) * 1992-06-08 1994-01-18 Genentech, Inc. Purified forms of DNASE
US6383788B1 (en) * 1994-03-04 2002-05-07 Genentech, Inc. Minimizing thermally induced aggregation of DNase in solution with calcium
US5580856A (en) * 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof

Also Published As

Publication number Publication date
DE69535787D1 (en) 2008-08-28
CA2184581C (en) 2005-02-22
US6383788B1 (en) 2002-05-07
EP0748377A1 (en) 1996-12-18
US20030054532A1 (en) 2003-03-20
JPH09503394A (en) 1997-04-08
US7018825B2 (en) 2006-03-28
JP3009224B2 (en) 2000-02-14
WO1995023854A1 (en) 1995-09-08
ATE401394T1 (en) 2008-08-15
EP0748377B1 (en) 2008-07-16

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Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20150302